Suture passer devices and methods

ABSTRACT

Devices, systems and methods for passing a suture. In general, described herein are suturing devices, such as suture passers, as well as methods of suturing tissue. These suture passing devices are dual deployment suture passers in which a first distal jaw member is moveable at an angle with respect to the longitudinal axis of the elongate body of the device and the second distal jaw member is retractable proximally to the distal end region of the elongate body and/or the first jaw member. Methods of suturing tissue using a dual deployment suture passer are also described.

CROSS REFERENCE TO RELATED APPLICATIONS

This patent application claims the benefit of priority to the followingprovisional patent applications: U.S. Provisional Patent Application No.61/483,200, titled “MENISCUS REPAIR”, filed on May 6, 2011, and U.S.Provisional Patent Application No. 61/511,922, titled “MENISCUS REPAIR”,filed on Jul. 26, 2011.

This patent application may be related to U.S. patent application Ser.No. 12/942,803, titled “DEVICES, SYSTEMS AND METHODS FOR MENISCUSREPAIR”, filed on Nov. 9, 2010, which claim priority to U.S. ProvisionalPatent Application Nos.: 61/259,572, titled “DEVICES, SYSTEMS EMS ANDMETHODS FOR MENISCUS REPAIR”, filed on Nov. 9, 2009; 61/295,354, titled“DEVICES, SYSTEMS AND METHODS FOR MENISCUS REPAIR”, filed on Jan. 15,2010; and 61/318,215, titled “CONTINUOUS SUTURE PASSERS HAVING TISSUEPENETRATING SUTURE SHUTTLES”, filed on Mar. 26, 2010.

All of these applications are herein incorporated by reference in theirentirety.

INCORPORATION BY REFERENCE

All publications and patent applications mentioned in this specificationare herein incorporated by reference in their entirety to the sameextent as if each individual publication or patent application wasspecifically and individually indicated to be incorporated by reference.

FIELD

The methods, devices and systems described herein may be used to suturetissue, particularly in difficult to access regions. In particular,described herein are highly maneuverable dual deployment suture passersconfigured to be deployed around a target tissue to be sutured.

BACKGROUND

Suturing of tissue during surgical procedures is time consuming and canbe particularly challenging in difficult to access body regions andregions that have limited clearance, such as regions partiallysurrounded or covered by bone. For many surgical procedures, it isnecessary to make a large opening in the human body to expose the arearequiring surgical repair. However, in many cases, accessing the tissuein this manner is undesirable, increasing recovery time, and exposingthe patient to greater risk of infection.

Suturing instruments (“suture passers” or “suturing devices”) have beendeveloped to assist in accessing and treating internal body regions, andgenerally assisting a physician in repairing tissue. Although many suchdevices are available for endoscopic and/or percutaneous use, thesedevices suffer from a variety of problems, including limited ability tonavigate and be operated within the tight confines of the body, risk ofinjury to adjacent structures, problems controlling the position and/orcondition of the tissue before, during, and after passing the suture, aswell as problems with the reliable functioning of the suture passer.

For example, some surgical instruments used in endoscopic procedures arelimited by the manner in which they access the areas of the human bodyin need of repair. In particular, the instruments may not be able toaccess tissue or organs located deep within the body or that are in someway obstructed. In addition, many of the instruments are limited by theway they grasp tissue, apply a suture, or recapture the needle andsuture. Furthermore, many of the instruments are complicated andexpensive to use due to the numerous parts and/or subassemblies requiredto make them function properly. Suturing remains a delicate andtime-consuming aspect of most surgeries, including those performedendoscopically.

For example, some variations of suture passers, such as those describedin U.S. Pat. No. 7,377,926 to Taylor, have opposing jaws that open andclose over tissue. One, or in some variations, both, jaws open,scissor-like, so that tissue may be inserted between the open jaws.Unfortunately, such devices cannot be adequately positioned for use inhard to navigate body regions such as the joints of the body, includingthe knee (e.g., meniscus) and the shoulder.

The meniscus is a C-shaped piece of fibrocartilage which is located atthe peripheral aspect of the joint (e.g., the knee) between the condylesof the femur and the tibia on the lateral and medial sides of the knee.The central ⅔^(rds) of the meniscus has a limited blood supply while theperipheral ⅓^(rd) typically has an excellent blood supply. Acutetraumatic events commonly cause meniscus tears in younger patients whiledegenerative tears are common in older patients as the menisci becomeincreasingly brittle with age. Typically, when the meniscus is damaged,a torn piece may move in an abnormal fashion inside the joint, which maylead to pain and loss of function of the joint. Early arthritis can alsooccur due to these tears as abnormal mechanical movement of tornmeniscal tissue and the loss of the shock absorbing properties of themeniscus lead to destruction of the surrounding articular cartilage.Occasionally, it is possible to repair a torn meniscus. While this maybe done arthroscopically, surgical repair using a suture has provendifficult because of the hard-to-reach nature of the region and thedifficulty in placing sutures in a way that compresses and secures thetorn surfaces.

Arthroscopy typically involves inserting a fiberoptic telescope that isabout the size of a pencil into the joint through an incision that isapproximately ⅛ inch long. Fluid may then be inserted into the joint todistend the joint and to allow for visualization of the structureswithin that joint. Then, using miniature instruments which may be assmall as 1/10 of an inch, the structures are examined and the surgery isperformed.

FIGS. 21A, 21B and 22 illustrate the anatomy of the meniscus in thecontext of a knee joint. As shown in FIG. 22 the capsule region (theouter edge region of the meniscus) is vascularized. Blood enters themeniscus from the menisculocapsular region 211 lateral to the meniscus.A typical meniscus has a flattened (“bottom”) and a concave top, and theouter cross-sectional shape is somewhat triangular. The outer edge ofthe meniscus transitions into the capsule. FIG. 23 illustrates thevarious fibers forming a meniscus. As illustrated in FIG. 23, there arecircumferential fibers extending along the curved length of themeniscus, as well as radial fibers, and more randomly distributed meshnetwork fibers. Because of the relative orientations and structures ofthese fibers, and the predominance of circumferential fibers, it may bebeneficial to repair the meniscus by suturing radially (vertically)rather than longitudinally or horizontally, depending on the type ofrepair being performed.

For example, FIGS. 24A-24E illustrate various tear patterns or injuriesto a meniscus. Tears may be vertical/longitudinal (FIG. 24A), Oblique(FIG. 24B), Degenerative (FIG. 24C), including radially degenerative,Transverse or radial (FIG. 24D) and Horizontal (FIG. 24E). Most priorart devices for suturing or repairing the meniscus are only capable ofreliably repairing vertical/longitudinal tears. Such devices are nottypically useful for repairing radial or horizontal tears. Furthermore,prior art device mechanisms have a high inherent risk for iatrogenicinjury to surrounding neurovascular structures and chondral surfaces.

Thus, there is a need for methods, devices and systems for suturingtissue, particularly tissue in difficult to access regions of the bodyincluding the joints (shoulder, knee, etc.). In particularly, it hasproven useful to provide a device that may simply and reliably reach andpass sutures within otherwise inaccessible tissue regions. Finally, itis useful to provide a suturing device that allows the tissue to besutured to be held within an adjustable jaw so that it can bepredictably sutured, and done so in a manner that protects fragilesurrounding tissues from iatrogenic injury. The methods, devices andsystems described herein may address this need.

SUMMARY OF THE DISCLOSURE

The present invention relates to devices, systems and methods forsuturing tissue, including a torn meniscus. In general, described hereinare suturing devices, such as suture passers, as well as methods ofaccessing and repairing tissue using these suture passers, includingmethods of suturing tissue. The device and methods described hereinallow methods of suturing and repairing tissue that were previouslyimpossible or impractical to perform during a surgical procedure.

The suture passers described herein may also be referred to as dualdeployment suture passers, because the tissue engaging region of thesuture passer comprises a distal-facing opening formed between two jaws(a first jaw member and a second jaw member), and each jaw member moves(is deployed) independently with a different type (e.g., axis, plane,range, etc.) of motion. Many of the devices described herein may also bereferred to as clamping/sliding suture passers, because the first jawmember acts to clamp onto the tissue, by changing the angle of the firstjaw member relative to the more proximal elongate body region of thedevice, and the second jaw member slides, moving axially relative to themore proximal elongate body region of the device.

Thus, in many of the dual deployment suture passer described herein, thefirst jaw member generally extends distally from a proximal elongatebody region; the angle of the first jaw member relative to the proximalelongate body region is adjustable. These dual deployment suture passersalso have a second jaw member that may be moved from a position proximalto the first jaw member and/or proximal to the distal end of theelongate body region to a distal position to form a distal-facing jawopening with the first jaw member.

Because of this novel jaw movement, a dual deployment suture passer mayreadily access and be positioned around tissue to be sutured in ways notpossible with more traditional suture passers. Generally a dualdeployment suture passer may be positioned within the tissue byadjusting the angle of the first jaw member to help avoid non-targettissue as the device is advanced so that the first jaw member isadjacent to the target tissue. The second jaw member may then beextended distally from the proximal position (e.g., by sliding axially,by swinging distally, etc.) so that the tissue is held between the firstand second jaw members in a distal-facing jaw opening. The tissue to besutured may then be clamped securely between the first and second jawmembers (e.g., by adjusting the angle of the first jaw member), and asuture may be passed between the two by extending a tissue penetratorfrom within one of the first or second jaw members, across the openingand through the tissue, to either drop off or pick up a suture at theopposite jaw member. The tissue penetrator can then be retracted backinto the jaw member that houses it.

For example, described herein are methods of arthroscopically placing asuture. The suture may be placed entirely arthroscopically. For example,two or fewer incisions may be made into the body (e.g., knee, shoulder,etc.), and a camera and suture passer may be placed within the knee. Inany of these methods, the suture may be placed by independently orsequentially moving a first distal jaw member through a first range ofmotion before, during or after placing the distal end of the suturepasser into the tissue region. A second jaw member is typically heldproximally to the first jaw member either within or aligned with themore proximal elongate body region of the suture passer. Afterpositioning the distal end of the suturing device, including thedistally-extending first jaw member against the target tissue to besutured, the second jaw member may be advanced distally until it ispositioned opposite from the first jaw member. The tissue may be securedbetween the first and second jaw members. In general the second jawmember may be moved into position by moving the second jaw member in apath of motion that is different from that of the first jaw member. Forexample, the first jaw member may be hinged to move at an angle relativeto the elongate body of the device, while the second jaw member extendsdistally (and retracts proximally) by sliding axially relative to theelongate body of the device.

For example, described herein are dual deployment suture passer devices.In some variations these devices include: an elongate body having aproximal end region and a distal end region; a first jaw memberextending from the distal end region of the elongate body and configuredfor angular movement relative to the elongate body; a second jaw memberconfigured to extend axially relative to the elongate body, the secondjaw configured to form an opening with the first jaw member when thesecond jaw member is axially extended; and a tissue penetratordeployably held within either the first or second jaw member andconfigured to pass a suture between the first and second jaw members byextending and retracting between the first and second jaw members whenthe first and second jaw members form the opening.

In some variations, the second jaw member may be contained within theelongate body; in other variations, it is held outside of the elongatebody (e.g., secured adjacent to the outside of the elongate body). Theelongate body may be straight, curved, or bendable; in someconfigurations the elongate body is tubular and extends as an elongatetube. In general, the elongate body may have any appropriatecross-section, including round, oval, square, triangular, or the like.The cross-section of the elongate body may be uniform, or it may varyalong the length. In some variations, the elongate body may be narrowertowards the distal end, which may allow the device to be inserted intovarious regions of the body.

In general, the device may be configured so that the tissue penetratorextends between the first and second jaw members when they are fullydeployed distally. In this configuration, they may be referred to asdistal opening or having a distal-facing opening. In some variations thefirst jaw member and the second jaw member are deployed or deployable toform a distal facing opening into which the target tissue can bepositioned or held. In some variations the distal opening formed betweenthe jaws is formed around the target tissue by placing the first or thesecond jaw members adjacent the target tissue and moving the other jawmember (e.g., second or first jaw members) on the opposite side of thetarget tissue.

The tissue penetrator may be any appropriate tissue penetrating member.For example, the tissue penetrator may be a needle or tissue penetratingprobe. The tissue penetrator may include a suture engagement region forreleaseably engaging a suture. In some variations the suture engagementregion is a hook, notch, clamp, grasper, eyelet, slot, or the like. Thesuture engagement region may be positioned at or near the distal end, orjust proximal to the distal end of the tissue penetrator. The distal endof the tissue penetrator may be sharp (e.g., pointed, beveled, etc.) orit may be substantially dull. The tissue penetrator may be a metal,polymeric, alloy, ceramic, composite, or other material. Shape memory orsuperelastic materials, including superelastic alloys (such as Nitinol)may be used. Thus, as mentioned, the device may include a sutureengagement region at or near a distal tip of the tissue penetratorconfigured to couple with a suture.

In general, the tissue penetrator may extend between the first andsecond jaw members only when the first and second jaw members arepositioned to form an opening between which tissue may be held. In somevariations the suture passer includes a lock or other element preventingor limiting (e.g., a limiter) the tissue penetrator motion fromextending between or beyond the first and second jaw members.

During operation, the tissue penetrator generally extends from eitherthe first or second jaw members, across the opening between the firstand second jaw members (including through any tissue between the jawmembers), to engage with a suture retainer on the opposite jaw. Thesuture retainer may hold a suture so that it can be engaged (grabbed) bythe tissue penetrator. For example, in some variations the tissuepenetrator extends across the opening between the first and second jawmembers until it engages with a suture held by the opposite jaw member(e.g., in a suture retainer); thereafter the tissue penetrator can beretracted back across the opening and pull the suture with it. In somevariations the suture is preloaded onto the tissue penetrator and thesuture retainer grabs the suture from the tissue penetrator (or thetissue penetrator deposits the suture in the suture retainer) and holdson the opposite jaw as the tissue penetrator is retracted back acrossthe opening and through any tissue there between.

The motion of the tissue penetrator may be regulated to prevent thetissue penetrator from extending beyond the opening formed between thefirst and second jaw members as it extends across this opening. Inparticular, a dual deployment suture passer may be configured to preventthe tip of the tissue penetrator from extending beyond the outside of ajaw member. Extending beyond the jaw member may result in damage tosurrounding (non-target) tissues. For example, the suture passer may beconfigured so that the extent of travel of the tissue penetrator islimited based on how “open” the jaw members are; in variations in whichthe size of the opening can be modified by adjusting the angle of thefirst jaw member relative to the elongate body of the device, a limitermay prevent the tissue penetrator from extending further beyond the sideof a jaw member opposite from the jaw member housing the tissuepenetrator. For example, the tissue penetrator may be configured toextend and retract between the first and second jaw members withoutextending substantially beyond a lateral side of the first or second jawmembers opposite the opening. Thus, the devices described herein mayalso include a movement limiter configured to limit the movement of thetissue penetrator based on a position of the first jaw member, thesecond jaw member or both the first and second jaw members, relative tothe elongate body.

In some variations the limiter (e.g., a travel limiter) may be employedto keep the tissue penetrator from extending beyond the opening andopposite jaw member. For example, a limiter may include a barrier,block, cage, or the like on the opposite jaw member preventing the tipof the tissue penetrator from extending beyond the jaw member when thetissue penetrator is extended across the opening.

Thus, the suturing device may also include a travel limiter configuredto prevent the tissue penetrator from extending substantially beyond alateral side of the first or second jaw members opposite the opening.

One of the jaw members (e.g., the second) jaw member may be configuredto move axially by extending distally or retracting proximally from thedistal end region of the elongate body. Thus, the second jaw member mayextend parallel to the long axis of the elongate body; in curvedvariations of the elongate body, the second jaw member extends distallyin the direction continuing the distally moving trajectory of theelongate body. The second jaw member may extend axially from within theelongate body, or from adjacent to the elongate body. In some variationsthe entire second jaw member may retract within the elongate body.

In some variations, the opening formed between the first and second jawmembers by extending the second jaw member distally is a distal-facingopening, as described above. In some variations the device includes aholdfast to hold one or both jaw element in a fixed position; theholdfast may be released or engaged by user control. For example, thesuturing device may include a first and/or second jaw holdfastconfigured to hold the first and/or second jaw members in a fixedposition relative to the elongate body. In one variation, the deviceincludes a first jaw holdfast configured to hold the first jaw member inan angular position relative to the elongate body and/or a second jawholdfast to hold the second jaw element in a fixed axial positionrelative to the elongate body.

Any of the device variations described herein may include a handle atthe proximal end of the device. The handle may be controlled by a user(e.g., surgeon) to actuate the various elements of the device, includingthe first jaw member, the second jaw member, and the tissue penetrator.The handle may therefore include one or more controls. For example, thedevice may include a first control for controlling the angular positionof the first jaw member relative to the elongate body and a secondcontrol for controlling the axial position of the second jaw memberrelative to the elongate body. These controls may be on the proximalhandle.

The device may also include an indicator for indicating when the secondjaw is in a predetermined axially extended position relative to theelongate body. The indictor may be visual, tactile, aural, or the like,including some combination of these. In some variations a separateindicator is not necessary; the full extension of the second (or first)jaw member may be the fully engaged position. Thus, when furtheractuation of the control (e.g., squeezing a trigger, moving a level,dial, or the like) does not result in any further actuation. In somevariations the control may “stop” when the jaw member is fully extended.

Thus, in some variations, the device includes a proximal handle havingcontrols for controlling at least one of the angular movement of thefirst jaw member, the axial movement of the second jaw member or theextension and retraction of the tissue penetrator.

Also described herein are suture passer devices (e.g., a dual deploymentsuture passers) comprising: an elongate body having a proximal endregion and a distal end region; a first jaw member extending from thedistal end region of the elongate body and configured for angularmovement relative to the elongate body; a second jaw member configuredto extend distally or retract proximally from the distal end region ofthe elongate body; and a tissue penetrator configured to pass a suturebetween the first and second jaws and further configured to extend andretract between the first and second jaw members when the second jawmember is extended distally to form a distal-facing opening with thefirst jaw member.

Any of the features described above may be included in these variationsas well. For example, the device may also include a suture engagementregion near a distal tip of the tissue penetrator, the suture engagementregion configured to couple with a suture. In some variations the devicealso includes a movement limiter configured to limit the movement of thetissue penetrator based on a position of the first jaw member, thesecond jaw member or both the first and second jaw members.

Also described herein are suture passer devices including: a hingedfirst jaw member extending from a distal end of an elongate body andconfigured to controllably bend relative to a longitudinal axis of theelongate body; an axially sliding second jaw member configured to extenddistally and retract proximally relative to the distal end of theelongate body to form a distal-facing opening with the first jaw memberwhen the second jaw member is extended distally; a tissue penetratorhoused within the second jaw member and configured to extend across thedistal-facing opening to the first jaw member; a suture engagementregion disposed near a distal end of the tissue penetrator andconfigured to engage a suture; and a travel limiter configured to engagethe tissue penetrator and prevent the tissue penetrator from extendingbeyond a lateral side of the first or second jaw members opposite thedistal-facing opening.

Although many of the device variations just described include a secondjaw member that is axial movable, in some variations the second jawmember is movable in other dimensions in addition to, or alternativelyto, the axial direction. Generally the second jaw member is movable in adirection that is different from the manner of movement of the first jawmember, and extends the second jaw member from a position in which thedistal end (e.g., tip) region of the second jaw member is proximal tothe distal end of the elongate body. Movement of the second jaw membermay be independent of the movement of the first jaw member.

Also described herein are methods of suturing a tissue, the methodcomprising: moving a first jaw member of a dual deployment suture passerso that the first jaw member extends distally from a proximal elongatebody region of the suture passer at an angle with respect to alongitudinal axis of the proximal elongate body region; positioning thefirst jaw member adjacent to a tissue to be sutured; extending a secondjaw member of the suture passer distally relative to the elongate bodyregion to form a distal-facing opening between the first and second jawmembers, so that the tissue to be sutured is within the distal-facingopening; and passing a suture through the tissue within thedistal-facing opening by moving a tissue penetrator coupled to a suturebetween the first and second jaw members.

The method may also include the step of preventing the tissue penetratorfrom extending beyond a lateral side of the first or second jaw membersopposite the distal-facing opening when passing the suture. In somevariations, the method also includes the step of retracting the secondjaw member proximally relative to the elongate body and withdrawing thesuture passer from the tissue.

This method may be used to treat (e.g., suture) as part of a variety oftreatments, including, but not limited to, repair of a torn meniscus,repair of a torn ACL, labral tear repair, hip labrum repair, spinal discrepair, etc. In any of these variations, the method of treatment (methodof suturing tissue) may include the step of positioning the first jawadjacent to the tissue to be sutured, such as the meniscus, labrium,ACL, spinal disc/annulus, etc. For example, the step of positioning thefirst jaw member may comprise positioning the first jaw member adjacentto meniscus tissue.

These devices and methods may be used as part of a minimally invasive(e.g., percutaneous) or open procedure. For example, the method ofsuturing may also include the step of percutaneously inserting thesuture passer near the tissue to be sutured.

The step of passing the suture through the tissue may comprise extendingthe tissue penetrator from the second jaw member through the tissue tothe first jaw member, engaging the suture held in the first jaw memberand retracting the tissue penetrator back to the second jaw member whileholding the suture with the tissue penetrator. In some variations, thestep of passing the suture through the tissue comprises extending thetissue penetrator coupled to a suture from the second jaw member throughthe tissue to the first jaw member, engaging the suture with a sutureretainer in the first jaw member and retracting the tissue penetratorback to the second jaw member.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 shows one variation of a dual deployment suture passer asdescribed herein.

FIGS. 2A through 2D illustrate actuation of the first jaw member, secondjaw member and tissue penetrator for one variation of a suture passer.

FIG. 3 is a side view of the suture passer shown in FIG. 1.

FIG. 4 is a front perspective view of the suture passer shown in FIG. 3in which the first jaw member is positioned at an angle relative to thelongitudinal axis of the elongate body of the device, and the second jawmember is extended fully distally relative to the elongate body to forma distal-facing jaw opening.

FIG. 5A is a side perspective view of the suture passer variation shownin FIG. 4 with the second jaw member retracted proximally.

FIG. 5B shows the suture passer of FIG. 5A with the second jaw extendeddistally; FIG. 5C shows FIG. 5B with the outer region of the elongatebody removed.

FIG. 6A shows a top perspective view of the suture passer shown in FIG.5A.

FIG. 6B shows a bottom perspective view of the suture passer of FIG. 5B.

FIG. 6C shows a bottom perspective view of the suture passer of FIG. 5C.

FIG. 7A shows a side view of one variation of a tissue penetrator.

FIG. 7B shows a side perspective view of the tissue penetrator of FIG.7A.

FIG. 8 shows the perspective view of FIG. 4 with a tissue penetratorpartially extended between the first and second jaw members, and with asuture loaded in the first jaw member.

FIGS. 9A-9C illustrate actuation of a suture passer such as the oneshown in FIG. 8 to pass a suture from the upper jaw to the lower jaw.

FIG. 10A shows a side view of one variation of the distal end region ofa suture passer, showing a first and second jaw member extended in toform a distal facing opening.

FIG. 10B shows another variation of the distal end region of a suturepasser with the first and second jaw member extended in to form a distalfacing opening.

FIG. 11 illustrates one variation of a first jaw member having a hingeallowing angular motion relative to the long axis of the elongate memberregion of the suture passer.

FIGS. 12A-12E illustrate operation of one variation of a dual deploymentsuture passer configured as a clamping/sliding suture passer.

FIGS. 13A-13C illustrate operation of one variation of a dual deploymentsuture passer configured as a clamping/side-swinging suture passer.

FIGS. 14A-14C illustrate operation of one variation of a dual deploymentsuture passer configured as a clamping/down-swinging suture passer.

FIGS. 15A-15C illustrate operation of one variation of a dual deploymentsuture passer configured as a clamping/complex motion suture passer.

FIGS. 16A-16C illustrate another variation of a dual deployment suturepasser configured so that the distal end of the tissue penetratorextends distally from the first jaw.

FIG. 17A shows one variation of a proximal handle with controls forcontrolling action of a dual deployment suture passer.

FIG. 17B shows another variation of a proximal handle with controls forcontrolling action of a dual deployment suture passer.

FIGS. 18A-18C show another variation of a suture passer as described.

FIGS. 19A-19F illustrate operation of one variation of dual deploymentsuture passer.

FIGS. 20A and 20B show a generic form of a dual deployment suturepasser.

FIGS. 21A and 21B illustrate the anatomy of the meniscus.

FIG. 22 illustrates the anatomy of the meniscus, including the capsuleand associated vascular tissue.

FIG. 23 illustrates the structure of a meniscus.

FIGS. 24A-24E illustrate various tear patterns that may be repairedusing the invention described herein.

FIGS. 25A-25H illustrate the use of a dual deployment suture passer tosuture a torn meniscus.

FIGS. 26A-26H illustrate the use of a dual deployment suture passer tosuture a labral tear.

FIGS. 27A-27G illustrate the use of a dual deployment suture passer torepair a hip labrum.

FIG. 28 shows an exemplary section through a spine showing a normaldisc;

FIG. 29 shows a similar section through a spine having a herniated disc.

FIGS. 30A-F illustrate the use of a dual deployment suture passer torepair a herniated disc.

FIGS. 31A-31F illustrate another example of using a dual deploymentsuture passer to repair a spinal region.

DETAILED DESCRIPTION

Described herein are suture passers. In general, these devices may bereferred to herein as suture passers, suturing devices. The devicesdescribed herein may also be referred to as dual deployment suturepassers, or in some variations, clamping/sliding suture passers.

In general, the suture passers described herein include a first jawmember and second jaw member that are configured to extend from the endof an elongate body region. FIG. 1 illustrates one variation of a dualdeployment suture passer 100. In this example, the device has a first(upper) jaw member 103 extending distally from the distal end of a moreproximal elongate member 101. A second jaw member 105 is shown extendeddistally beneath the first jaw member 105. A handle 107 is located atthe proximal end of the device and includes multiple controls forindependently controlling the movements of the first jaw member, secondjaw member, and tissue penetrator. The handle in this example alsoincludes a second jaw member lock for locking/unlocking the movement ofthe second jaw member.

The suture passer shown in FIG. 1 is positioned with the first jawmember held at an angle relative to the long axis of the proximalelongate member. The first jaw member in this example is shown having ahinge region 113 about which the first jaw member may be angled relativeto the elongate member. In some variations this hinge region is a pinnedhinge; non-pinned (e.g., living hinges) regions may be used. Anyappropriate articulating region that allows the first jaw member to moveat an angle relative to the proximal portion of the device (e.g., theelongate member) may be used. In some variations this first jaw memberis referred to as an upper jaw member, but alternative variations (inwhich the first jaw member is a lower jaw member) are also possible.

The first jaw member may be actuated by any appropriate mechanism,including a tendon member (e.g., push rod, pull rod, or the like), andmay be held (locked) at any angle (e.g., between 0° and 180° relative toa line extending from the distal end of the elongate body, between about0° and 90°, between about 0° and 60°, etc.). In some variations thedevice has a neutral position during which no force is applied to thecontroller to move the first jaw member, so that the first jaw member isangled “open” (e.g., at 30°, 45°, 50°, 90° or at any angle between about15° and about 90° relative to the elongate body; actuating the controlon the handle results in the first jaw member moving towards the“closed” position (e.g., reducing the angle with respect to a lineextending from the distal end of the elongate body).

The first jaw member shown in FIG. 1 also includes a suture retainerregion near the distal end (described in greater detail below). Thissuture retainer region may hold the suture or be configured to hold asuture. In some variations the suture retainer includes a channel orguide for holding the suture in a preferred position. In some variationsthe suture retainer includes a pair of graspers, or deflectable membersinto which the suture may be pushed and held (e.g., handed off from thetissue penetrator). A suture retainer generally holds the suture so thatit can be either removed by the tissue penetrator, or so that a suturecan be passed into the suture retainer from the tissue penetrator. InFIG. 1, the suture retainer is a channel across which the suture extendsso that it can be reliably engaged and pulled down by the tissuepenetrator as described in more detail below. In some variations thesecond jaw member includes a suture retainer, rather than the first jawmember.

The second jaw member is shown in FIG. 1 as a lower jaw member. In thisvariation, the lower jaw member is configured to slide proximallytowards and into the proximal elongate body of the device. The secondjaw member typically moves axially, in the direction of theproximal-distal axis of the suture passer. In some variations the secondjaw member moves axially completely past the distal end of the elongatebody; alternatively, the second jaw member slide axially in the proximaldirection only partially (e.g. to align with the hinge region of thefirst jaw member). The second jaw member shown in FIG. 1 retractscompletely into, and extends out of, the lower portion of the elongatebody. In some variations the second jaw member moves axially in parallelwith the lower jaw member, or only a portion of the lower jaw memberextends into the elongate body.

A tissue penetrator (not shown in FIG. 1) may be housed within eitherthe first or second jaw member. As described in more detail below, thetissue penetrator may be configured as a needle, wire, knife, blade, orother element that is configured to extend from within either the firstor second jaw members and across the opening between the jaw members toengage a suture retainer and either drop off or pick up a suturetherefrom. In general, the tissue penetrator may be configured tocompletely retract into the jaw member housing it. It may be extendedacross the opening between the jaws by actuating a member in the handleto push or otherwise drive it across the opening, and though any tissueheld between the jaws.

The second jaw member 105 shown in FIG. 1 completely houses the tissuepenetrator and includes a deflection region that drives the tissuepenetrator up and out of the second jaw member by deflecting it acrossthe opening between the two.

The elongate body 101 shown in FIG. 1 is illustrated as a relativelystraight cylindrical body, though other shapes may be used. For example,the elongate body may be curved, bent, or angled. In some variations theelongate body is configured to be bent, curved or angled dynamically(e.g. by changing the bend or curve).

The elongate body may be any appropriate length. For example, theelongate body may be between about 6 and about 24 inches long, e.g., 6inches long, 8 inches long, 10 inches long, 12 inches long, etc. Thesuture passers described herein may be used for arthroscopic surgeriesand therefore may be dimensioned for use as such. Thus the diameter ofthe device may be configured to be small enough for insertion into acannula, tube or the like for insertion into the body.

FIGS. 2A-2D illustrate one variation of the distal end region of a dualdeployment suture passer forming a distal-facing opening and extending atissue penetrator across the distal opening. For example, in FIG. 2A thedistal end of the device is shown with the first jaw member 201 (shownhere as an upper jaw member) extended distally at 0° relative to a lineextending from the distal end of the elongate body 203. This “straight”configuration may be helpful for inserting and/or removing the distalend of the device into the tissue (e.g., through a cannula). The firstjaw member can then be bent, or allowed to bend in some variations, atan angle relative to a line extending from the distal end of theelongate body.

In this example, the first jaw member pivots around an hinge point 205,and is controlled by a pulling member 208 that pushes and/or pullsproximally and/or distally to control the bend of the first jaw member.The pulling member may include a shaft, wire, tendon, tube, cannula, orthe like, and may extend to the proximal end of the device where it canbe controlled. The arrow 211 in FIG., 2A illustrates the plane anddirection of motion of the first jaw member.

In FIG. 2B the first jaw member has been moved (or allowed to move) sothat it forms an angle of approximately 30° with a line extending fromthe distal end of the elongate body. The arrow 214 in FIG. 2Billustrates the direction of axial motion that the lower jaw (not yetvisible in FIG. 2B) will be moved. This is illustrated in FIG. 2C, inwhich the lower jaw member 207 has been extended distally from theproximal region of the device. In this example the second jaw member 207is shown fully extended distally relative to the elongate body region203. Although this example shows the second jaw member extending fromcompletely within the elongate body region (as in FIG. 2B), in somevariation the lower jaw member is held outside of the elongate bodyregion, or only partially within the elongate body region. In somevariations the second jaw member is completely retracted proximally sothat much (or all) of the second jaw member is held proximal to thedistal end of the elongate body region 203.

Once the first and second jaw members are completely extended distally(as shown in FIGS. 2C and 2D, the tissue penetrator may be sent acrossthe distal-facing opening 222 as shown in FIG. 2D. In general, thetissue penetrator may be prevented from exiting the opposite side of thejaw member by a limiter (e.g. a travel limiter and/or a movementlimiter). In FIG. 2A-2D the first jaw member includes a cage or shieldregion 232 that prevents the tip of the tissue penetrator from extendingout of the first jaw member where it may cut or damage the non-targettissue. In some variations the device may also include a movementlimiter, which limits the movement of the tissue penetrator so that itcan only extend to just couple with the opposite jaw member (and pass orgrab a suture held therein). Since the jaws may be open to varyingpositions, a movement limiter may help prevent the tissue penetratorfrom overextending even when the first jaw member is only slightlyangled with respect to a line extending from the distal end of theelongate body.

In some variations the tissue penetrator may be prevented from extendingacross the opening between the first and second jaw members unless thesecond (axial moving) jaw member is extended distally relative to theelongate body. This may allow the tissue penetrator to mate properlywith the suture engagement region on the first jaw member. For example,a lock or other mechanism may be used to prevent the tissue penetratorfrom engaging with a control at the proximal end of the device until thesecond jaw member is fully extended.

A side view of the device shown in FIGS. 1-2D is provided in FIG. 3.

FIG. 4 shows a front perspective view of the distal end region of thedevice of FIGS. 1-3 with the second jaw member extended fully distallyand the first jaw member angled slightly (e.g., approximately 30°relative to a line extending distally from the longitudinal axis of theelongate body). In this variation the lower jaw member 403 may beconfigured to fit within the upper jaw member 401 when the two jawmember s are closed down on one another (not shown). Thus the upper(first) jaw member 401 is wider than the lower (second) jaw member 403.The first jaw member in this example also includes optional side windows402. The first jaw member may also include a suture engagement region;in FIG. 4, this suture engagement region includes a channel 409 throughthe midline (extending proximally to distally) and a first 415 andsecond 417 notch or protrusion 405 cut into the first jaw member. Asuture may be wrapped around the first jaw member by passing from theproximal end of the device, under the proximal notch 417 and along thebottom (e.g., the side of the first jaw facing the extended second jaw)around the distal end of the first jaw member and along the top (e.g.,the side of the first jaw facing away from the second jaw) and, underthe distal notch 415 and back up out of the proximal notch 417 so thatthe suture may extend distally. This loop of suture held by the sutureengagement region of the jaw member may be held under sufficient tensionso that the suture may be engaged by the suture engagement region of thetissue penetrator (e.g., hook, grasper, etc.). In some variation atensioning member may be included in the suture engagement region.

In some variations (not shown here) the suture may be contained withinthe elongate body of the device. Alternatively, the suture may be keptoutside of the device. In some variations the suture may be loaded bythe user. For example, a user may load a suture on the device by placinga loop of suture over the first jaw member. In some variation sutureholder may be placed along the length of the device to hold or managethe suture so that it doesn't interfere with the operation of the deviceor get tangled.

FIGS. 5A-5C and 6A-6C illustrate different views of the first and secondjaw members in one variation. For example, in FIG. 5A the first jawmember is shown with the second jaw member retracted proximally. FIG. 6Ashows a top perspective view of the same first jaw member shown in FIG.5A. In FIG. 6A, the first jaw member includes a channel 605 extendingalong the longitudinal length of the first jaw member; this channel mayform part of the suture engagement region. The channel may hold thesuture so that it extends along the midline of the first jaw member onthe underside of the first jaw member. The notches 607, 609 in the firstjaw member near the proximal end extend toward the midline of the firstjaw member and allow the suture to pass from the top of the first jawmember to the bottom and back out, as discussed above. Thus, the suturemay be held close to the elongate body of the device even when the firstjaw is open to various angles.

FIG. 6B illustrates the underside or bottom of the first jaw membershown in FIG. 6A. The suture management region is the entire openingformed at the distal end. This cavity 613 is surrounded by the inside ofthe first jaw member, and (as mentioned above) may act as a limiter tolimit the tip of the tissue penetrator from extending outside of thefirst jaw member. FIG. 6C shows the same view as in FIG. 6B, but withthe second jaw member axially extended distally.

Returning now to FIG. 5B, a side view of the distal end of one variationof a suture passer is shown with the second jaw member 503 extendeddistally. FIG. 5C shows the same view as in FIG. 5B but with the outercannula 502 covering for the elongate member removed, showing theconnection between the second jaw member and the pushing/pulling element(rod 505). The pushing/pulling element may be a wire, shaft, tendon, orthe like, allowing the second jaw member 503 to be controllably sliddistally and proximally. Not visible in FIGS. 5A-6C is the tissuepenetrator, which is fully retracted into the second jaw member in thisexemplary embodiment.

FIG. 7A shows one variation of a tissue penetrator 700 as describedherein. In this example, the tissue penetrator includes a sharp, pointeddistal tip 701 and just proximal to the distal tip is a sutureengagement region configured as a hooked cut-out region 703. Theproximal end of the tissue penetrator includes a coupling region forcoupling the tissue penetrator with a pusher/puller mechanism, such as ashaft, rod, wire, tendon, or the like.

FIG. 8 shows the same perspective view of FIG. 4, but with the tissuepenetrator 803 partially extended across the distal-facing openingformed between the first jaw member 801 and the second jaw member 803. Asuture 808 is looped around the first jaw member 801. Both ends of thesuture pass into the notched region and are held close to the elongatebody, allowing the loop of suture to be held in tension within thesuture engagement region.

FIG. 9A-9C illustrate the variation of the device described abovepassing a suture from the first jaw member to the second jaw member. InFIG. 9A, the distal end of the second jaw member for the dual deploymentsuture passer has been extended fully. The upper jaw is held at an anglerelative to the elongate body region of the device proximal to the joint(e.g., hinge, bend region, etc.) of the first jaw member. A suture hasbeen loaded into the suture engagement region, and extends along thelength of the midline of the first jaw member. In FIG. 9B, the first jawmember has been moved slightly (decreasing the angle between the firstjaw and the fully extended lower jaw member. This may be typically ofsituations in which tissue is held between the first and second jawmembers. Clamping the tissue to be sutured in this manner allows thetissue to be secured within the jaws, preventing it from movingundesirably, and helping the tissue penetrator to penetrate through thetissue. Further, in FIG. 9B the tissue penetrator has been extended fromthe lower second jaw member across the distal-facing opening, towardsthe first jaw member and the suture retained therein. Once the tissuepenetrator contacts the suture, it may be grabbed or otherwise engagedby the suture engagement member of the tissue penetrator. Thereafter,the suture can be pulled back down with the tissue penetrator as itretracts back into the second jaw member. In this variation, the loop ofsuture is pulled back through the tissue.

Although the variation of the suture passer shown and discussed aboveincludes relatively straight first and second jaw members, otherconfiguration of jaw members is possible. For example, FIGS. 10A and 10Billustrate two variations of the upper jaw member. In particular, FIG.10B shows a variation in which the straight jaw member of the first jawmember is instead a curved jaw member; the curve may allow a greaterthickness of tissue to be placed between the jaws and may also be usefulfor navigating certain tissue regions, such as the labrum and ACL.

In general, the first jaw member in many of the variations describedherein may be dynamically angled with respect to the elongate body ofthe device. The first jaw member may be connected to and extend from thedistal end of the elongate body, or may be connected to an intermediateregion between the elongate body and the first jaw member. For example,in FIG. 11, a first jaw member is hinged to the elongate body, so thatit can be controllable moved to change the angle between with theelongate body long axis. The first jaw member hinge 1103 thus allows theposition of the first jaw member 1101 to be adjusted (e.g., more openedor closed) as device is positioned within the body towards a desiredtissue to be sutured. This adjustability may allow the suturing deviceto be inserted further into the space, hence farther from any insertioncannula 1109. This scissoring jaw mechanism, in combination with theabsence of a second (lower) jaw member, which may be retractedproximally, enables the device to surround a target tissue without beingtrapped within the cannula 1109 opening (the jaws don't have to beopened as traditional jaws would be) as it is being positioned.

For example, FIGS. 12A-12E illustrate one variation of the operation ofa dual deployment suturing device in which the first (upper) jaw memberis hinged and the second (lower) jaw member slides axially relative tothe elongate body region proximal to the first jaw member. This designallows the device to surround tissue in difficult to reach areas, whileat the same time protecting nearby tissue from iatrogenic damage. InFIG. 12A a cannula has been placed within the body near the targettissue. Non-target tissue to be avoided is also nearby. For example thenon-target tissue region may be a nerve, an artery, a vein, bone,cartilage, etc. In FIG. 12B, the suturing device is extended from thecannula with the distal end of the first jaw member leading. The firstjaw member may be held in a horizontal position (at an angle of 0°relative to the long axis of the elongate body). In this example, thesecond jaw member is retracted proximally and is therefore kept out ofthe way of the distal end region of the device as it is positioned nearthe target tissue. In FIG. 12C the first jaw member is angled “up” (atan angle of about 30° with respect to the long axis of the elongatebody) allowing the device to maneuver around the potentially sensitivenon-target tissue so that it can be positioned adjacent to the targettissue. All of these maneuvers may be performed with the help ofvisualization, such as arthroscopic visualization. In FIG. 12D, once thefirst jaw member is adjacent to the tissue, the second jaw member may bedistally extended by moving axially from the distal end of the elongatebody, as shown. This motion of the second jaw member may also bereferred to as a telescoping motion, as it is extending out of theproximal region toward the distal end by axially sliding. As the secondjaw member extends distally it surrounds the tissue between the firstand second jaw members, forming a distal-facing opening in which thetarget tissue resides, as shown in FIG. 12E. Thereafter, the tissuepenetrator may be extended between the first and second jaw members,allowing the tissue penetrator to pass the suture from the first to thesecond jaw member. When the suture has been passed and the tissuepenetrator retracted back into the second jaw member, the second jawmember may be retracted back towards the elongate member, proximally,and the entire device withdrawn from the tissue or away from the targettissue. The suture passing through the tissue may then be knotted orotherwise anchored.

FIGS. 13A to 13C illustrate operation of another variation of a suturepasser in which the second jaw member is a side swinging member. In thisvariation the second jaw member extends from the proximal portion (e.g.,behind the first jaw member or the hinge of the first jaw member) todistal position by a side swinging motion. Although this motion wouldnot be permitted everywhere in the body, there may be some variations inwhich this side swinging motion may be desired.

FIGS. 14A-14C illustrate operation of another variation of a suturepasser having a first jaw member that swings from a proximally locatedposition (e.g., proximal to the upper jaw) to a distal position able toform a distal-facing jaw opening with the first jaw member. In thisvariation the second jaw member swings down (away from the long axis ofthe device) and back up to be positioned distally and opposite the firstjaw member as shown in FIG. 14B and 14C.

Other variations of motion of the second jaw member are possible,including compound motions that combine more than one of the axialmotion, side-swinging motion and down-swinging motion. For example,FIGS. 15A-15C illustrate a second jaw member having a compound orcomposite motion. In any of these variations, the second jaw membertypically goes from a retracted position in which it is held proximal tofirst jaw member and/or proximal to the distal end of the elongate body,to an extended distal direction.

The position of the first jaw member and the second jaw member may beseparately and/or independently controlled. For example, any of thevariations described herein may include a proximal handle havingcontrols for controlling the activation of the first jaw member, thesecond jaw member, and the tissue penetrator. For example, FIG. 17A isan enlarged view of the handle region of the suture device discussedabove in FIGS. 1-3. In this example, the handle includes a control tocontrol the motion of the first jaw member (which may also be referredto herein as a clamp trigger) 1603, a second jaw member control 1605 (orlower jaw handle), and a tissue penetrator control 1607 (or needletrigger). Additional controls may include a lower jaw screw lock to lockthe position of the law jaw member. The operation of this handlevariation in controlling a dual deployment suture passer is describedbelow with respect to FIGS. 19A-19F.

FIG. 17B illustrates another variation of a handle for a dual deploymentsuture passer. In this variation the handle controls aretriggers/handles. The proximal trigger 1705 is a squeeze handle thatcontrols the angle of the first jaw member 1703 relative to the elongatebody. The control and handle are configured with a bias element (spring1707) that tends to keep the first jaw member at an angle with respectto the elongate member; in this example, the angle is about 30° relativeto a line extending distally from the long axis of the elongate bodyregion of the device. A second grip control 1709 controls the extensionof the second (lower) jaw member (not visible in FIG. 17B). In thisvariation a second biasing element (spring) 1711 tends to hold thecontrol so that the second jaw element is retracted proximally and, inthis example, into the elongate member. A third trigger control 1715controls the extension of the tissue penetrator. This control isarranged to include a lock that prevents the control from engaging withthe tissue penetrator until the second jaw member is completelyextended. Further, the control also includes a travel limiter 1721 thatlimits how far the tissue penetrator may be extended from within thesecond jaw element based on how angled the first jaw member is,preventing the tissue penetrator from trying to extend beyond the firstjaw element.

In any of the devices described herein, the controls may be handles ortriggers (as illustrated in FIGS. 17A and 17B) or other controls, suchas dials, buttons, sliders, switches, or the like.

Although many of the suture passer devices (including the dualdeployment suture passers described above) limit the travel of thetissue penetrator to prevent it from extending beyond the opposite jawmember from where it is housed when not extended, in some variations itmay be beneficial to allow the tissue penetrator to extend distally outof the opposite jaw member, as illustrated in FIGS. 16A-16C. In thisexample the tissue penetrator is deflected within the opposite jawmember and allowed to extend distally out of the opposite jaw membersome amount (e.g., less than 5 mm, less than 4 mm, less than 3 mm,etc.). For example, as shown in FIG. 16A, the tissue penetrator may behoused in the second jaw member and may be deployed across thedistal-facing opening formed when the first and second jaw members areextended fully distally. The tissue penetrator is shown partiallyextended from the second jaw member in FIG. 16A, however it should beunderstood that the tissue penetrator (including the tip of the tissuepenetrator) may be fully retraced or retractable into the second jawmember. Also, for convenience in FIGS. 16A-16C, the jaw members areshown close together, e.g., with only a little space between the firstand second jaw members; the jaws may be more opened, for example, bymoving the first (upper) jaw member at an angle with respect to the moreproximal region of the device.

In FIG. 16B the tissue penetrator 1622 extends from within the secondjaw and across the distal-facing opening to pass into an opening on theopposite (first or upper) jaw member. The tip of the needle is pointedin this example, and a side region of the needle proximal to the pointeddistal tip is recessed to form a suture engagement region that ishook-shaped. Extending the needle into and partially out of the firstjaw member as shown in FIG. 16B allows the suture engagement region onthe tissue penetrator to engage the suture held by the first jaw member,as shown. The tissue penetrator in this example extends out of thedistal end of the first jaw member distally (not laterally) and islimited to extending just a finite amount (e.g., less than 4 mm) fromthe distal tip of the first jaw member. In FIG. 16C, the tissuepenetrator is retracted back to the second jaw member, pulling thesuture with it in the suture engagement region.

The variation of the suture passer illustrated in FIGS. 16A-16C in whichthe tip of the tissue penetrator extends distally, has various featuresor advantages including simplifying the coordination between the variousparts. For example, less coordination is required to limit the needlemotion (e.g., stopping it before it crashes into the first or upperjaw). This may allow greater tolerances, and the parts may require lessprecision. Also, extending the tissue penetrator distally may allow for“over travel” of the tissue penetrator and provide for more reliableengagement (hooking) of the suture by the suture engagement region. Thedistal end of the first jaw member may include sufficient space for thetissue penetrator to over-travel the suture so that the hook (sutureengagement feature) on the tissue penetrator can grab the suture on itsway back to the lower (second) jaw member. With this variation, theheight of the first jaw member can be compressed sizably, and theover-travel necessary to pick up the suture is directed in a manner thatdoesn't require additional height. Further, the additional over-travelopportunity offered by this configuration may allow use of a symmetricdistal tip region for the suture penetrator, e.g., having a point is inthe middle of the tissue penetrator distal tip region. Asymmetric tissuepenetrators may also be used (e.g., having a point is on one side of thetissue penetrator). However, the asymmetric tissue penetrators may havea greater propensity to deviate from the desired needle trajectorytowards the direction of the needle point.

FIGS. 18A-18C illustrate another variation of a suture passer. In FIG.18A, the second jaw member is not retracted proximally, and the firstand second jaw members are clamped together. The first jaw member may beopened as shown in FIG. 18B, and the tissue penetrator may be extendedacross the distal-facing opening, as shown in FIG. 18C.

Methods of Use

In general, the devices described herein may be used to suture anyappropriate tissue. These devices are particularly well suited forpassing a suture in a minimally invasive procedure to reach difficult toaccess regions. Examples of the use of these devices are provided below,and illustrated in FIGS. 19A to 31F.

The general operation of one variation of a dual deployment suturepasser is illustrated in FIGS. 19A-19F. The clamping/sliding suturepasser illustrated in FIG. 19A includes a handle such as the one shownin FIG. 17A, above. Before use, a suture may be loaded on the first jawmember of the device. For example, a loop of suture may be loaded ontothe first jaw member. The free ends of the suture may be coupled to asuture control element such as a tensioning screw, as shown in FIG. 19A.For example, the two free ends may be cinched onto a tensioner screw.The suture passer may be loaded outside of the body by the user, or itmay be pre-loaded. Once loaded, the suture passer may be inserted intothe body near the target tissue. For example, the device may be insertedinto the body through a cannula. As shown in FIG. 19A, the second(lower) jaw member may be fully retracted proximally, and the upper jawmay be clamped down fully so that it is in-line with (straight) relativeto the elongate member; the first jaw member may be locked in thisposition for insertion, or it may be moved or dynamically adjusted as itis inserted.

Thereafter, the device may be positioned relative to the target tissue.For example, the first jaw member may be positioned adjacent to thetarget tissue. As shown in FIG. 19B, the device may then be positionedand the clamp trigger adjusted or released.

Once the tissue is adjacent to the first jaw member, the second jawmember may be extended to surround a target tissue, as shown in FIG.19C. In this example, the control for the second jaw member (the lowerjaw lock) may be actuated to slide the lower jaw member distally,forming the distal-facing opening, and surrounding (at least partially)the target tissue to be sutured. As shown in FIG. 19C, this may beachieved by sliding in and locking the lower jaw with the lower jawhandle by releasing the lower jaw screw lock and sliding the lower jawinto position. The lower (second) jaw may then be locked in a fullyextended position.

The upper (first) jaw member may be adjusted to clamp or hold the targettissue securely between the upper and lower (first and second) jawmembers, as illustrated in FIG. 19D. Thereafter, the tissue penetratormay be actuated (e.g., by squeezing the needle trigger) to extend fromwithin the lower jaw member, through the tissue between the first andsecond lower jaw members, and across to the upper jaw. To engage asuture held within the suture engagement region in the upper jaw. Thetissue penetrator may then pick up the suture from the upper jaw andpull it back down through the tissue, as shown in FIGS. 19D and 19E.

Once the suture has been hooked, the tissue penetrator may be retracedback into the second jaw member (in this example), as shown in FIG. 19F,and the lower jaw member may be retraced proximally, in the reverse tothe process described above, so that the suture passer, which havingpassed the suture successfully, may be withdrawn from the patient.

FIGS. 20A-20B show a generic version of a dual deployment suture passer.FIG. 20A shows a suture passer having a second jaw member in a retractedstate; FIG. 20B shows the same suture passer with the lower jaw in anextended state. This generic schematic of a dual deployment (e.g.,clamping/sliding) suture passer may be used to illustrate operation ofthe device in different tissues.

Any of the devices described herein may be used to suture and treat atorn meniscus of the knee. For example, in FIGS. 25A-25H a torn meniscus2503 is repaired using the device as discussed above. In FIG. 25A thesuture passer 2505 is inserted into the knee with just the first jawmember extended. The jaw member can easily fit between the femur andtibia of the knee to approach the meniscus 2501. The first jaw membercan then be slid between the superior surface of the meniscus and thefemur (as shown in FIG. 25B). The angle of the first jaw member may bedynamically adjusted as the suture passer is inserted to best match thetissue. This procedure may be observed arthroscopically. Thereafter, thesecond jaw member 2507 may be advanced under the meniscus between theinferior surface of the meniscus and the tibia, until the second jawmember is fully extend and the target tissue, including the meniscaltear 2503 is surrounded within the jaws of the device as shown in FIG.25C.

The meniscus tissue may then be clamped between the first and second jawmembers, and the tissue penetrator may be extended across the tissue, asshown in FIG. 25D. The arrow indicates the direction of the tissuepenetrator from the lower (second) jaw member, through the meniscus andinto the upper (first) jaw member. The tissue penetrator may then engagethe suture held in the first jaw member. The tissue penetrator isprevented (e.g., by a limiter) from extending beyond the upper jawmember, and may then be retracted, as shown in FIG. 25E, by withdrawingthe tissue penetrator back down through the meniscus and into the lower(second) jaw member, pulling the suture loop with it. In FIG. 25F, thesuture has been completely drawn through the meniscus and the tissuepenetrator completely retracted. Thereafter the lower jaw member mayalso be withdrawn by axially retracting it proximally, as shown in FIG.25G. The suture passer may then be withdrawn from the meniscus, as shownin FIG. 25H. The looped suture may be pulled so that one free end of thesuture is pulled through the meniscus (leaving a single suture length,rather than a loop of suture passing though the meniscus). The suturemay then be knotted.

FIGS. 26A-26H illustrate another variation of a method of using thesuture passer devices described herein to treat a patient. In thisexample, the method is used to treat a Bankart tear, an anteriorinferior (or posterior inferior) labral tear. FIG. 26A illustrates thelabral tear. In FIG. 26B the suture passer is inserted into the shoulderand the first jaw member is positioned (by dynamically adjusting theangle of the first jaw member) adjacent to the torn tissue, as shown inFIG. 26C. In FIG. 26C, the first jaw member is placed over the labrumand the anterior-inferior capsule. The lower (second) jaw member maythen be axially extended so that the jaws now encompass thelabro-capsular region, as shown in FIG. 26D. The first jaw may beadjusted to clamp the target tissue securely between the jaws and thetissue penetrator may be extended to pass a suture between the jaws, asshown in FIG. 26E. The lower (second) jaw member may then be retracted,and the device may be removed, as shown in FIG. 26G. A knot or tie maythen be slid over the suture ends to tide off the suture as shown inFIG. 26H.

The suture passer devices and methods describe herein may also be usedto repair a hip labrum, as illustrated in FIGS. 27A-27G. In FIG.27A-27B, the hip labrum may be approached by the suture passer havingthe second jaw member retracted and the first jaw member extendeddistally. The angle of the first jaw member may be dynamically adjustedto help pace the suture passer near the labrum to be sutured, as shownin FIG. 27C. In FIG. 27D, the second jaw member may be axially extendedfrom a proximal position to slide beneath the labrum and form adistal-facing opening so that the first and second jaw members surroundthe labrum tissue as shown in FIG. 27D. In FIG. 27E the tissuepenetrator may then be extended across the distal-facing opening andthrough the tissue to grab (or in some variations drop off) a suture inthe suture engagement region of the opposite jaw member. The tissuepenetrator can then be retracted, and the second jaw member can also beretracted proximally, as shown in FIG. 27F. Finally, the device can bewithdrawn from the tissue, as shown in FIG. 27G.

In any of the methods described herein the device may be controlled fromthe proximal end by a handle such as those illustrated above (e.g.,FIGS. 17A and 17B). The device may be controlled using a single hand.

FIGS. 28, 29, 30A-30F and 31A-31F illustrate the use of a suture passerdevice such as the one illustrate herein to repair spinal tissue. Forexample, FIG. 28 shows a normal disc of a spine (a schematicillustration of a section through the spine is shown). In contrast, FIG.29 shows a herniated disc. Traditionally this region has been difficultto access and thus difficult to suture. One variation of a device asdescribed herein may be used to suture the disk annulus. For example, inFIG. 29A shows a suture passer as descried herein approaching theherniated disc. The angle of the first jaw member may be dynamicallyadjusted to help position the first jaw member adjacent to the tissue(e.g., the annuls) to be sutured. Once in position, as shown in FIG.30B, the second jaw member may be extended so that the tissue to betreated is between the jaws, as shown in FIG. 30C. Thereafter the tissuepenetrator may be extended across the jaws and through the tissue eitherto push a suture to the opposite side, or in some variations, to pullthe suture from the opposite side back through the tissue. The secondjaw member may then be retracted and the entire device withdrawn fromthe disc region, as shown in FIG. 30F, leaving the suture behind.

In general, a suture may be passed from the first jaw member to thesecond jaw member or vice versa. Further, the tissue penetrator may beconfigured to push the suture through the tissue or it may be configuredto pull the suture through the tissue; the suture engagement region onthe opposite side of the jaw from that housing the tissue penetrator maybe adapted for either receiving a suture (e.g., having a clamping regionor gripping region, a hook, or the like) or for passing on a suture(e.g., holding the suture in position where it may be grabbed by thetissue penetrator). In addition, the tissue penetrator may be in eitherthe second jaw member (as primarily illustrated above) or it may be inthe first jaw member; the appropriate engagement region may be presenton the opposite jaw as well.

FIGS. 31A-31F show another view of the method for suturing an annulus ofa disc of a spine. For example, in FIGS. 31A to 31C, the suture passerincluding an extended first jaw member approaches the torn tissue to besutured. In FIG. 31D the second jaw member is axially extended on theopposite side of the tissue to be sutured, and the tissue penetrator isextended to pass the suture through the tissue. In FIG. 31 the tissuepenetrator has been retracted and the second jaw member has also beenretracted, so that the suturing device may be withdrawn while pullingthe suture through the tissue, as shown in FIG. 31F.

Although the foregoing invention has been described in some detail byway of illustration and example for purposes of clarity ofunderstanding, it is readily apparent to those of ordinary skill in theart in light of the teachings of this invention that certain changes andmodifications may be made thereto without departing from the spirit orscope of the invention.

Although the description above is broken into parts and includesspecific examples of variations of suture passers, any of the featuresor elements described in any particular example or section may beincorporated into any of the other embodiments. Although the foregoinginvention has been described in some detail by way of illustration andexample for purposes of clarity of understanding, it is readily apparentto those of ordinary skill in the art in light of the teachings of thisinvention that certain changes and modifications may be made theretowithout departing from the spirit or scope of the appended claims.

1. A suture passer device comprising: an elongate body having a proximalend region and a distal end region; a first jaw member extending fromthe distal end region of the elongate body and configured for angularmovement relative to the elongate body; a second jaw member configuredto extend axially relative to the elongate body, the second jawconfigured to form an opening with the first jaw member when the secondjaw member is axially extended, wherein the second jaw member isconfigured to move independently of the first jaw member; and a tissuepenetrator deployably held within either the first or second jaw memberand configured to pass a suture between the first and second jaw membersby extending and retracting between the first and second jaw memberswhen the first and second jaw members form the opening.
 2. The device ofclaim 1, wherein the tissue penetrator is configured to extend andretract between the first and second jaw members without extendingsubstantially beyond a lateral side of the first or second jaw membersopposite the opening.
 3. The device of claim 1, wherein the second jawmember is configured to move axially by extending distally or retractingproximally from the distal end region of the elongate body.
 4. Thedevice of claim 1, wherein the opening formed by extending the secondjaw member comprises a distal-facing opening.
 5. The device of claim 1,further comprising a suture engagement region near a distal tip of thetissue penetrator, the suture engagement region configured to couplewith a suture.
 6. The device of claim 1, further comprising a travellimiter configured to prevent the tissue penetrator from extendingsubstantially beyond a lateral side of the first or second jaw membersopposite the opening.
 7. The device of claim 1, further comprising amovement limiter configured to limit the movement of the tissuepenetrator based on a position of the first jaw member, the second jawmember or both the first and second jaw members, relative to theelongate body.
 8. The device of claim 1, further comprising a second jawholdfast configured to hold the second jaw member in an axial positionrelative to the elongate body.
 9. The device of claim 1, furthercomprising a first jaw holdfast configured to hold the first jaw memberin an angular position relative to the elongate body.
 10. The device ofclaim 1, further comprising a first control for controlling the angularposition of the first jaw member relative to the elongate body and asecond control for controlling the axial position of the second jawmember relative to the elongate body.
 11. The device of claim 1, furthercomprising an indicator for indicating when the second jaw is in apredetermined axially extended position relative to the elongate body.12. The device of claim 1, further comprising a proximal handle havingcontrols for controlling at least one of the angular movement of thefirst jaw member, the axial movement of the second jaw member or theextension and retraction of the tissue penetrator.
 13. The device ofclaim 1, wherein the tissue penetrator is housed and extends from withinthe second jaw member.
 14. A suture passer device comprising: anelongate body having a proximal end region and a distal end region; afirst jaw member extending from the distal end region of the elongatebody and configured for angular movement relative to the elongate body;a second jaw member configured to extend distally or retract proximallyfrom within the distal end region of the elongate body; and a tissuepenetrator configured to pass a suture between the first and second jawsand further configured to extend and retract between the first andsecond jaw members when the second jaw member is extended distally toform a distal-facing opening with the first jaw member.
 15. The deviceof claim 14, further comprising a suture engagement region near a distaltip of the tissue penetrator, the suture engagement region configured tocouple with a suture.
 16. The device of claim 14, further comprising amovement limiter configured to limit the movement of the tissuepenetrator based on a position of the first jaw member, the second jawmember or both the first and second jaw members.
 17. The device of claim14, further comprising a second jaw holdfast configured to hold thesecond jaw member in an axial position relative to the elongate body.18. The device of claim 14, further comprising a first jaw holdfastconfigured to hold the first jaw member in an angular position relativeto the elongate body.
 19. The device of claim 14, further comprising afirst control for controlling the angular position of the first jawmember relative to the elongate body and a second control forcontrolling the axial position of the second jaw member relative to theelongate body.
 20. The device of claim 14, further comprising a travellimiter preventing the tissue penetrator from extending beyond a lateralside of the first or second jaw members opposite the distal-facingopening.
 21. The device of claim 14, further comprising a proximalhandle having controls for controlling at least one of the angularmovement of the first jaw member, the axial movement of the second jawmember and the extension and retraction of the tissue penetrator. 22.The device of claim 14, wherein the tissue penetrator is housed andextends from within the second jaw member.
 23. A suture passer devicecomprising: a hinged first jaw member extending from a distal end of anelongate body and configured to controllably bend relative to alongitudinal axis of the elongate body; an axially sliding second jawmember configured to extend distally and retract proximally relative tothe distal end of the elongate body to form a distal-facing opening withthe first jaw member when the second jaw member is extended distally; atissue penetrator housed within the second jaw member and configured toextend across the distal-facing opening to the first jaw member; asuture engagement region disposed near a distal end of the tissuepenetrator and configured to engage a suture; and a travel limiterconfigured to engage the tissue penetrator and prevent the tissuepenetrator from extending beyond a lateral side of the first or secondjaw members opposite the distal-facing opening.
 24. (canceled) 25.(canceled)
 26. (canceled)
 27. (canceled)
 28. (canceled)
 29. (canceled)30. (canceled)
 31. The device of claim 1, wherein the opening betweenthe first and second jaws is an angular opening.
 32. The device of claim1, wherein the second jaw member is configured to retract into thedistal end region of the elongate body.
 33. The device of claim 1,wherein the second jaw member is configured to retract into the distalend region of the elongate body so that most or all of the second jawmember is held proximal to the distal end of the elongate body.
 34. Thedevice of claim 14, wherein the second jaw member is configured toretract into the distal end region of the elongate body so that most orall of the second jaw member is held proximal to the distal end of theelongate body.